Back to resultsEvaluating Vitamin D Content in Mushrooms
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mushroom Vitamin D2
Cholecalciferol
Vitamin D2 - Ergocalciferol
Mushroom Extract
Sponsored by
About this trial
This is an interventional other trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
- All healthy adults, male and female, age 18-64 years
Exclusion Criteria:
- Currently taking, or having taken less than one month prior to start of study, a prescription of 50,000 IU of vitamin D2 or 2000 IU vitamin D2 or vitamin D3
- Allergy to mushrooms
- History of elevated calcium (>10.4 mg%)
- Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- Supplementation with over the counter formulations of vitamin D2 or vitamin D3
- Subjects with a history of an adverse reaction to orally administered vitamin D.
- Subjects who are taking oral Dilantin or glucocorticoids.
- Exposure to a tanning bed or tanning on a beach for more than eight hours with no sunscreen within 2 weeks prior to start of study.
- History of intestinal malabsorption (i.e. cystic fibrosis, fat malabsorption syndrome, Crohn's Disease, gastric bypass surgery).
- Subjects with any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Placebo Comparator
Arm Label
2000 IU Vitamin D3- Cholecalciferol
2000 IU Vitamin D2- Ergocalciferol
2000 IU Mushroom Vitamin D2
Mushroom Extract
Arm Description
Take 2000 IU crystalline vitamin D3 once/day for 12 weeks.
Take 2000 IU crystalline vitamin D2 supplement once/day for 12 weeks.
Take 2000 IU vitamin D2 in a mushroom supplement once/day for 12 weeks
Capsules with mushroom extract and no vitamin D. The intervention is mushroom extract.
Outcomes
Primary Outcome Measures
Changes in total 25(OH)D in mushroom supplement or crystalline supplement
The primary outcome of this study is to examine changes in total 25(OH)D levels after ingestion of a vitamin D2 mushroom supplement manufactured by Monterey Mushrooms, Inc. compared to crystalline vitamin D2 from Nature's Life or vitamin D3 manufactured by Whole Health, Inc.
Secondary Outcome Measures
Changes in gene expression due to mushroom supplement or crystalline supplement
The secondary outcome is to look at changes in gene expression, specifically if ingestion of 2000 IU vitamin D2 in a dried mushroom extract and the same quantity of mushroom extract once/day for three months has any added benefits or differences compared to taking crystalline vitamin D2 or vitamin D3.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01815437
Brief Title
Evaluating Vitamin D Content in Mushrooms
Official Title
Evaluation of Vitamin D in a Mushroom Supplement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate how much vitamin D is present in a mushroom supplement. This supplement contains an extract from mushrooms that have been exposed to sunlight. The mushroom supplement will be compared to non-commercially available vitamin D supplements produced in a Goo Manufacturing Practices (GMP)-licensed facility.
Detailed Description
Mushrooms have the capability to produce vitamin D in a similar way to human skin. When exposed to ultraviolet light, mushrooms will convert a precursor to vitamin D. This reaction produces large amounts of vitamin D. This study is comparing a natural source of vitamin D to a synthetic source of vitamin D and will help determine if mushrooms are a novel source for this essential nutrient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2000 IU Vitamin D3- Cholecalciferol
Arm Type
Active Comparator
Arm Description
Take 2000 IU crystalline vitamin D3 once/day for 12 weeks.
Arm Title
2000 IU Vitamin D2- Ergocalciferol
Arm Type
Active Comparator
Arm Description
Take 2000 IU crystalline vitamin D2 supplement once/day for 12 weeks.
Arm Title
2000 IU Mushroom Vitamin D2
Arm Type
Experimental
Arm Description
Take 2000 IU vitamin D2 in a mushroom supplement once/day for 12 weeks
Arm Title
Mushroom Extract
Arm Type
Placebo Comparator
Arm Description
Capsules with mushroom extract and no vitamin D. The intervention is mushroom extract.
Intervention Type
Dietary Supplement
Intervention Name(s)
Mushroom Vitamin D2
Other Intervention Name(s)
Ergocalciferol
Intervention Description
2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Intervention Description
2000 IU crystalline cholecalciferol once/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D2 - Ergocalciferol
Other Intervention Name(s)
Ercocalciferol
Intervention Description
2000 IU vitamin D2, ergocalciferol once/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Mushroom Extract
Intervention Description
Same quantity of mushroom extract in a capsule
Primary Outcome Measure Information:
Title
Changes in total 25(OH)D in mushroom supplement or crystalline supplement
Description
The primary outcome of this study is to examine changes in total 25(OH)D levels after ingestion of a vitamin D2 mushroom supplement manufactured by Monterey Mushrooms, Inc. compared to crystalline vitamin D2 from Nature's Life or vitamin D3 manufactured by Whole Health, Inc.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in gene expression due to mushroom supplement or crystalline supplement
Description
The secondary outcome is to look at changes in gene expression, specifically if ingestion of 2000 IU vitamin D2 in a dried mushroom extract and the same quantity of mushroom extract once/day for three months has any added benefits or differences compared to taking crystalline vitamin D2 or vitamin D3.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All healthy adults, male and female, age 18-64 years
Exclusion Criteria:
Currently taking, or having taken less than one month prior to start of study, a prescription of 50,000 IU of vitamin D2 or 2000 IU vitamin D2 or vitamin D3
Allergy to mushrooms
History of elevated calcium (>10.4 mg%)
Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
Supplementation with over the counter formulations of vitamin D2 or vitamin D3
Subjects with a history of an adverse reaction to orally administered vitamin D.
Subjects who are taking oral Dilantin or glucocorticoids.
Exposure to a tanning bed or tanning on a beach for more than eight hours with no sunscreen within 2 weeks prior to start of study.
History of intestinal malabsorption (i.e. cystic fibrosis, fat malabsorption syndrome, Crohn's Disease, gastric bypass surgery).
Subjects with any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F Holick, PhD, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17634462
Citation
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Results Reference
background
PubMed Identifier
18524740
Citation
Rovner AJ, O'Brien KO. Hypovitaminosis D among healthy children in the United States: a review of the current evidence. Arch Pediatr Adolesc Med. 2008 Jun;162(6):513-9. doi: 10.1001/archpedi.162.6.513.
Results Reference
background
PubMed Identifier
19661054
Citation
Kumar J, Muntner P, Kaskel FJ, Hailpern SM, Melamed ML. Prevalence and associations of 25-hydroxyvitamin D deficiency in US children: NHANES 2001-2004. Pediatrics. 2009 Sep;124(3):e362-70. doi: 10.1542/peds.2009-0051. Epub 2009 Aug 3.
Results Reference
background
PubMed Identifier
19064511
Citation
Looker AC, Pfeiffer CM, Lacher DA, Schleicher RL, Picciano MF, Yetley EA. Serum 25-hydroxyvitamin D status of the US population: 1988-1994 compared with 2000-2004. Am J Clin Nutr. 2008 Dec;88(6):1519-27. doi: 10.3945/ajcn.2008.26182.
Results Reference
background
PubMed Identifier
16497887
Citation
Liu PT, Stenger S, Li H, Wenzel L, Tan BH, Krutzik SR, Ochoa MT, Schauber J, Wu K, Meinken C, Kamen DL, Wagner M, Bals R, Steinmeyer A, Zugel U, Gallo RL, Eisenberg D, Hewison M, Hollis BW, Adams JS, Bloom BR, Modlin RL. Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response. Science. 2006 Mar 24;311(5768):1770-3. doi: 10.1126/science.1123933. Epub 2006 Feb 23.
Results Reference
background
PubMed Identifier
19237723
Citation
Ginde AA, Mansbach JM, Camargo CA Jr. Association between serum 25-hydroxyvitamin D level and upper respiratory tract infection in the Third National Health and Nutrition Examination Survey. Arch Intern Med. 2009 Feb 23;169(4):384-90. doi: 10.1001/archinternmed.2008.560.
Results Reference
background
PubMed Identifier
18089691
Citation
Holick MF, Biancuzzo RM, Chen TC, Klein EK, Young A, Bibuld D, Reitz R, Salameh W, Ameri A, Tannenbaum AD. Vitamin D2 is as effective as vitamin D3 in maintaining circulating concentrations of 25-hydroxyvitamin D. J Clin Endocrinol Metab. 2008 Mar;93(3):677-81. doi: 10.1210/jc.2007-2308. Epub 2007 Dec 18.
Results Reference
background
PubMed Identifier
21118827
Citation
Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.
Results Reference
background
PubMed Identifier
19858440
Citation
Pietras SM, Obayan BK, Cai MH, Holick MF. Vitamin D2 treatment for vitamin D deficiency and insufficiency for up to 6 years. Arch Intern Med. 2009 Oct 26;169(19):1806-8. doi: 10.1001/archinternmed.2009.361. No abstract available.
Results Reference
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Evaluating Vitamin D Content in Mushrooms
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